The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue
Primary Purpose
Carotid Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
simvastatin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing carotid endarterectomy
- No previously known side effects of statins
- Patients who will sign an informed consent
- Age > 18 years old
- No signs of current infection
Exclusion Criteria:
- Patient hypersensitive to any component of this medication
- Patients with acute liver disease (AST> normal value)
- Patients with chronic liver disease (history of Hepatitis B or C)
- Patients with renal failure (creatinine > 3.0)
- Patients with unexplained muscle pains and aches
- Patients with rheumatoid arthritis
- Patients with Lupus
- Current cancer treatment
- Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone
- Pregnant females
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Two 80 mg pills simvastatin taken 24 hours prior to surgery
Two 80 mg pills placebo are taken 24 hours prior to surgery
Outcomes
Primary Outcome Measures
This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure.
Secondary Outcome Measures
Full Information
NCT ID
NCT00587717
First Posted
December 21, 2007
Last Updated
February 14, 2011
Sponsor
Mayo Clinic
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00587717
Brief Title
The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue
Official Title
The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Two 80 mg pills simvastatin taken 24 hours prior to surgery
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Two 80 mg pills placebo are taken 24 hours prior to surgery
Intervention Type
Drug
Intervention Name(s)
simvastatin
Other Intervention Name(s)
Zocor
Intervention Description
Two 80 mg pills simvastatin taken 24 hours prior to surgery
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
take 2 80 mg pills placebo 24 hours prior to surgery
Primary Outcome Measure Information:
Title
This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure.
Time Frame
24 prior to surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing carotid endarterectomy
No previously known side effects of statins
Patients who will sign an informed consent
Age > 18 years old
No signs of current infection
Exclusion Criteria:
Patient hypersensitive to any component of this medication
Patients with acute liver disease (AST> normal value)
Patients with chronic liver disease (history of Hepatitis B or C)
Patients with renal failure (creatinine > 3.0)
Patients with unexplained muscle pains and aches
Patients with rheumatoid arthritis
Patients with Lupus
Current cancer treatment
Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone
Pregnant females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Lerman, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue
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